NCT07256392Phase 3Enrolling by invitation

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2028-09Estimated

Enrollment · participants1370Estimated

Source updated2026-08-27Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-06-03 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Enrolling by invitation

Check registry source

Posted 2025-12-03 · 1 field changed

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

Check registry source

Study details

Conditions studied

Chronic Spontaneous Urticaria

Treatments or interventions studied

barzolvolimabBiological

Primary outcomes · main study measures

Read the study measures

measure: Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.; description: The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.; timeFrame: From Day 1 (baseline) to Week 52.; measure: Time to disease worsening or treatment failure through Week 52 based on the occurrence of the discontinuation of barzolvolimab in Group 2 due to lack of efficacy or to a treatment related adverse event.; description: Evaluate duration of efficacy of barzolvolimab on urticaria activity or to a treatment related adverse event.; timeFrame: From Day 1 (baseline) to Week 52.; measure: Time to disease worsening or treatment failure through Week 52 based on the occurrence of first use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1.; description: Evaluate duration of efficacy of barzolvolimab on urticaria activity leading to initiation of either a confounding prohibited medication (Group 1 or 2) or barzolvolimab in Group 1.; timeFrame: From Day 1 (baseline) to Week 52.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history